Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000190505
Ethics application status
Approved
Date submitted
16/05/2006
Date registered
18/05/2006
Date last updated
4/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Smoking Cessation Program Following Diagnosis of a Potentially Curable Cancer
Scientific title
A prospective cohort study of current and recent ex-smokers offered enrolment in a smoking cessation program following diagnosis of a potentially curable cancer: an examination of factors determining success in quitting and subsequent effect on quality of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Potentially curable cancer (any type) 1165 0
Condition category
Condition code
Cancer 1250 1250 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A motivational interview session with a smoking cessation nurse, for approximately 1.5 hours
Intervention code [1] 1046 0
None
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1687 0
Prolonged abstience rate
Timepoint [1] 1687 0
At 12 months
Secondary outcome [1] 3023 0
Determine prolonged abstinence
Timepoint [1] 3023 0
At 1, 3 and 6 months
Secondary outcome [2] 3024 0
Determine point-prevalence abstinence rates
Timepoint [2] 3024 0
At 1, 3, 6, and 12 months
Secondary outcome [3] 3025 0
Assess associations between prolonged abstinence status at 12 months and level of nicotine dependence, demongraphic factors, type of cancer, patient readiness to abstain, distress score, quality of life, efficacy of inital anti-cancer treatment, toxicity of inital anti-cancer treatment.
Timepoint [3] 3025 0
Secondary outcome [4] 3026 0
Compare quitters and non-quitters with respect to change in quality of life and distress
Timepoint [4] 3026 0
Secondary outcome [5] 3027 0
Identify barriers and difficulties in the quitting process
Timepoint [5] 3027 0

Eligibility
Key inclusion criteria
Signed informed consent- presence of a potentially curable cancer which is newly diagnosed and histologically confirmed- treatment policy established for curative intent- current smoker or recent ex smoker- ability to participate in the first interview with a quit counsellor within a week of registration- high likelihood of surviving for at least 12 months- available for 12 month follow up- ability to speak, read and write English sufficiently well- access to a telephone at home.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inital treatment for cancer commenced more than two weeks prior to study registration- active current history of unstable psychiatric illness or significant cognitive deficits.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1363 0
Charities/Societies/Foundations
Name [1] 1363 0
Foundation grant
Country [1] 1363 0
Funding source category [2] 1364 0
Other Collaborative groups
Name [2] 1364 0
RACP fellowship grant
Country [2] 1364 0
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Country
Australia
Secondary sponsor category [1] 1204 0
None
Name [1] 1204 0
None
Address [1] 1204 0
Country [1] 1204 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2722 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2722 0
Ethics committee country [1] 2722 0
Australia
Date submitted for ethics approval [1] 2722 0
Approval date [1] 2722 0
23/02/2006
Ethics approval number [1] 2722 0
06/05

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36138 0
Address 36138 0
Country 36138 0
Phone 36138 0
Fax 36138 0
Email 36138 0
Contact person for public queries
Name 10235 0
Anna Ugalde
Address 10235 0
Education Centre - Level 3
Locked Bag 1 A'Beckett St
East Melbourne
Victoria 8006
Country 10235 0
Australia
Phone 10235 0
61 3 9656 1798
Fax 10235 0
61 3 9656 1337
Email 10235 0
[email protected]
Contact person for scientific queries
Name 1163 0
Linda Mileshkin
Address 1163 0
Department of Medical Oncology
Locked Bag 1 A'Beckett St
East Melbourne
Victoria 8006
Country 1163 0
Australia
Phone 1163 0
61 3 9656 3719
Fax 1163 0
Email 1163 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.